ML20128N509
| ML20128N509 | |
| Person / Time | |
|---|---|
| Issue date: | 10/11/1996 |
| From: | Charles Brown NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Berger A HNU SYSTEMS, INC. |
| Shared Package | |
| ML20128N514 | List: |
| References | |
| SSD, NUDOCS 9610160412 | |
| Download: ML20128N509 (1) | |
Text
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october 11,-1996 A. W. Berger, RSO HNU Systems, incorporated 160 Charleme> t Street Newton, MA 02161-9987
Dear Mr. Berger:
This letter is in response to your letter dated August 29,1996, concerning whether an amendment to your registration certificate is required to import and distribute electron capture detectors manufactured and assembled in Finland. After a review of your current registration certificate, it has been determined that an amendment to your registration is required. Please submit the information below if you plan to request an amendment to your registration.
In reviewing your current registration and supporting documents, it was noted that your Quality Assurance / Control Program needs to be updated to include requirements placed on HNU-Nordion to ensure design conformance and removable contamination has been done. HNU System, Inc. must provide assurance that devices received from HNU-Nordion have been tested for this criteria. The guidelines set forth in Regulatory Guide 6.9,
- Establishing Quality Assurance Programs for the Manufacturer and Distribution of Sealed Sources and Device of Byproduct Material" (copy enclosed) may be used to assist you in providing this information. In particular, you will need to provide details concerning receipt inspection or final testing, including identification of the components and dimensions inspected or tested.
i In addition, your amendment request should contain a statement ve,ifying that there are no other changes to the information in the original application.
If I can provide further clarification, please contact me at (301) 415-5787 or John Lubinski at (301) 415-7868.
Sincerely, Christopher L. Brown, Genera! Engineer Sealed Source Safety Section Medical, Academic, and Commercial Use Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards
Enclosure:
As stated j
Distribution:
SSSS r/f NE01 y-
, NR-0330-D-102-G l
DOCUMENT NAME: C:\\ OFFICE \\WPWIN\\WPDOCS\\HNU.LTR T2 receive a copy of this document, indicate in the boa:
"C" = Copy without 1ttachment/gnclosure
'E" = Copy with attachment / enclosure "N" = No copy lOF FICE IMAB l
IMAB % N l f) l lNAME CBrowrF JLubinsRi lDATE 10/7/96 10/996 OFFICIAL RECORD COPY 9610160412 961011 PDR RC SSD PDR